Efficacy of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma

Introduction: Patients with moderate or severe, uncontrolled asthma are often prescribed biologic therapies to improve disease control and reduce asthma exacerbations. The efficacy of different biologics in reducing asthma exacerbations associated with hospitalization or an emergency department (ED) visit has varied across randomized controlled trials (RCTs). This study summarizes published US Food and Drug Administration-approved biologic efficacy data for exacerbations that required hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma. Methods: A PubMed literature search (24 May 2024) identified phase 2b/3 RCTs of omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tezepelumab. Annualized asthma exacerbation rate (AAER) ratios for exacerbations that required hospitalization or an ED visit, or hospitalization regardless of an ED visit, were extracted. A pooled efficacy estimate of the AAER ratio for exacerbations that required hospitalization or an ED visit across the RCTs was assessed using a meta-analysis based on a random effects model. The percentage of total variation across all included RCTs that was due to heterogeneity was calculated (I²). Results: Among 308 articles identified, nine publications describing 10 RCTs reported relevant AAER ratio data. No suitable omalizumab data were identified. In all trials, biologic treatment showed a reduction versus placebo in the AAER for exacerbations that required hospitalization or an ED visit, except in one of two benralizumab studies and both reslizumab studies. The pooled efficacy estimate showed a 56% reduction (95% CI 37–69) in the AAER for exacerbations requiring hospitalization or an ED visit (I², 59.93%; p = 0.0075). One of three mepolizumab trials and both tezepelumab trials showed a reduction versus placebo in the AAER for exacerbations that required hospitalization regardless of an ED visit. Conclusion: These findings suggest that there may be differential effects of biologics in reducing exacerbations that require hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.